Trial reportArthritis research & therapy2012
Efficacy and safety of lenalidomide for refractory cutaneous lupus erythematosus.
Trial report in Arthritis research & therapy, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01408199 (Phase II Study To Evaluate The Safety And Efficacy Of Lenalidomide For The Treatment Of Refractory Cutaneous Lupus), which is not on this map. Cited by 25 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Phase II Study To Evaluate The Safety And Efficacy Of Lenalidomide For The Treatment Of Refractory Cutaneous Lupus
Who cites it
25 citing papers in PubMed, 1 synthesis or guideline pooled it, 77 citations in OpenAlex.
- Discoid lupus erythematosus and its progression to systemic lupus erythematosus across age groups: a systematic review.Journal of medicine and life · 2025Pooled it
- Lenalidomide in treatment-refractory cutaneous lupus erythematosus: Efficacy and safety in a 52-week trial.Journal of the American Academy of Dermatology · 2014Trial
- Immunotargets and Therapy for Systemic Lupus Erythematosus.ImmunoTargets and therapy · 2025Review
- Diagnosis and Management of Cutaneous Manifestations of Autoimmune Connective Tissue Diseases.Clinical, cosmetic and investigational dermatology · 2022Review
- Effects of targeting the transcription factors Ikaros and Aiolos on B cell activation and differentiation in systemic lupus erythematosus.Lupus science & medicine · 2021Article
- The CLASI, a validated tool for the evaluation of skin disease in lupus erythematosus: a narrative review.Annals of translational medicine · 2021Review
- Recent Insight on the Management of Lupus Erythematosus Alopecia.Clinical, cosmetic and investigational dermatology · 2021Review
- Candidate drug replacements for quinacrine in cutaneous lupus erythematosus.Lupus science & medicine · 2020Review
- Cutaneous Lupus Erythematosus: Progress and Challenges.Current allergy and asthma reports · 2020Review
- Cutaneous Lupus Erythematosus: Current and Future Pathogenesis-Directed Therapies.The Yale journal of biology and medicine · 2020Review
- Review
- Advances in Cutaneous Lupus Erythematosus and Dermatomyositis: A Report from the 4th International Conference on Cutaneous Lupus Erythematosus-An Ongoing Need for International Consensus and Collaborations.The Journal of investigative dermatology · 2019Article
- Current Insights Into The Management Of Discoid Lupus Erythematosus.Clinical, cosmetic and investigational dermatology · 2019Article
- Advancing understanding, diagnosis, and therapies for cutaneous lupus erythematosus within the broader context of systemic lupus erythematosus.F1000Research · 2019Review
- Lupus community panel proposals for optimising clinical trials: 2018.Lupus science & medicine · 2018Review
- Multiple Myeloma Presenting with Autoimmune Autonomic Ganglionopathy.Internal medicine (Tokyo, Japan) · 2017Article
- Lenalidomide for refractory cutaneous manifestations of pediatric systemic lupus erythematosus.Lupus · 2017Article
- Two cases demonstrating thalidomide's efficacy in refractory lupus nephritis.Clinical rheumatology · 2017Review
- Therapeutic options for cutaneous lupus erythematosus: recent advances and future prospects.Expert review of clinical immunology · 2016Review
- Practice and Educational Gaps in Lupus, Dermatomyositis, and Morphea.Dermatologic clinics · 2016Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionCutaneous lupus erythematosus (CLE) is a chronic disease characterized by disfigurement and a relapsing course. Thalidomide has proven its efficacy in refractory cutaneous lupus disease, although it is not exempt from significant side effects and frequent relapses after withdrawal. New thalidomide analogues have been developed but lack clinical experience. The aim of this preliminary phase II study was to evaluate the efficacy and safety of lenalidomide in patients with refractory CLE.
methodsFifteen patients with refractory cutaneous lupus disease were enrolled in this single-center, open-label, non-comparative pilot trial between January 2009 and December 2010. Oral lenalidomide (5 to 10 mg/day) was administered and tapered according to clinical response. Patients were followed up for a mean of 15 months (range: 7 to 30). Primary efficacy endpoint was the proportion of patients achieving complete response, defined by a Cutaneous Lupus Erythematosus Disease Area and Severity index (CLASI) activity score of 0. Other secondary endpoints included development of side effects, evaluation of cutaneous and systemic flares, and impact on the immunological parameters.
resultsOne patient discontinued treatment due to side effects. All remaining patients saw clinical improvement and this was already noticeable after 2 weeks of treatment. Twelve of those patients (86%) achieved complete response but clinical relapse was frequent (75%), usually occurring 2 to 8 weeks after lenalidomide's withdrawal. No influence on systemic disease, immunological parameters or CLASI damage score was observed. Side effects including insomnia, grade 2 neutropenia and gastrointestinal symptoms, were minor (13%). These resolved after withdrawing medication. Neither polyneuropathy nor thrombosis was observed.
conclusionLenalidomide appears to be efficacious and safe in patients with refractory CLE, but clinical relapse is frequent after its withdrawal.
trial registrationClinicalTrials.gov: NCT01408199.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.